Avaliação de um cosmético oncológico na prevenção e tratamento de radiodermite: ensaio clínico randomizado triplo cego controlado

Abstract

Breast cancer is a neoplasm that affects a large part of the female population, and radiotherapy is one of the pillars of treatment for this disease, leading to reduced mortality. Radiodermatitis (RD) is one of the most common side effects of radiotherapy treatment, characterized as an apparently advisable evidence of excessive exposure to ionizing radiation, which causes dehydration and can lead to ulceration or secondary complications. The present study was justified by the need for adequate management of this occurrence to avoid skin damage that affects the well-being and quality of life of patients, aiming to evaluate an oncological cosmetic for the prevention and treatment of radiodermatitis for patients undergoing radiotherapy treatment. The participants of the study were randomly allocated to the test or control group. The efficacy of the test cream was evaluated in comparison with the Aloe vera control cream, through the weekly classification of the degree and appearance of radiodermatitis and measurements of the levels of hydration, oiliness, hydrolipidic balance and pH of the skin, as well as the quality of life of the patients, which was obtained through the EORTC QLQ-C30 questionnaire. The data obtained were obtained by statistical analysis, considering the value of p <0.05 significant. Both groups analyzed presented similar sociodemographic and clinical-pathological characteristics, leading to the interference of these factors in the comparison between the creams. The visual evaluation of the progression of DR shows that, in the last week of treatment, 43.3% of the patients in the control group presented DR grade I and 6.7% grade II, while for the test group, 34.4% of the patients manifested DR grade I and there was no participant with grade ≥2. In both groups there were no cases of DR grade ≥3. The test cream also showed a potential delay in the onset of radiodermatitis, with fewer participants presenting RD in the third week compared to the control group. Both creams were able to maintain the levels of hydration, oiliness and hydrolipidic balance of the participants' skin, with the test cream proving to be more effective than the control in maintaining pH. In addition, both products were well accepted sensorially by the patients and maintained the participants' quality of life unchanged.